Clinical TrialJun 2, 2026, 08:16 AM
Celcuity's Gedatolisib Trial Shows 50% Lower Risk of Progression in Breast Cancer
AI Summary
Celcuity Inc. announced detailed efficacy and safety results from the PIK3CA mutant cohort of its Phase 3 VIKTORIA-1 clinical trial for gedatolisib. The gedatolisib-triplet regimen demonstrated a statistically significant improvement in progression-free survival (PFS), doubling the likelihood of survival without disease progression or death compared to alpelisib plus fulvestrant. The company plans to submit these data to the FDA for a supplemental New Drug Application and anticipates potential FDA approval in Q3 2026.
Key Highlights
- Celcuity's gedatolisib-triplet showed a 50% reduction in risk of disease progression or death vs. alpelisib + fulvestrant (HR=0.50).
- Median PFS for gedatolisib-triplet was 11.1 months vs. 5.6 months for alpelisib + fulvestrant.
- Objective response rate (ORR) for gedatolisib-triplet was 48.9% vs. 26.0% for alpelisib + fulvestrant.
- Gedatolisib-triplet demonstrated the highest ORR reported in any Phase 3 trial for second-line HR+/HER2- ABC.
- Gedatolisib-doublet showed a 49% reduction in risk of disease progression or death vs. alpelisib + fulvestrant (HR=0.51).
- Median PFS for gedatolisib-doublet was 11.3 months vs. 5.6 months for alpelisib + fulvestrant.
- The company plans to submit these data to the FDA for a supplemental New Drug Application (sNDA).
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